Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-09-30

Brief Summary

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This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity.

The implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.

Detailed Description

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Conditions

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Otorhinolaryngologic Diseases

Keywords

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porous titanium implants thyroplasty vocal cord paralysis male or female more than 18 years old

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Mandibular prosthesis made of a new highly biointegratable material

Replacement of mandibular bone after partial or total mandible resection,avoiding then bone grafting. The porous titanium prosthesis is implanted under general anaesthesia in laryngeal surgeries. Bone resection and prosthesis placement is performed during the same surgical intervention. The prosthesis is attached onto the healthy bone with surgical screws. Simultaneous grafting of vascularised tissues may be done if the prosthesis surrounding area has been strongly irradiated.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female more than 18 years old

Exclusion Criteria

* Age less than 18 years old
* Pregnant women
* Local carcinoma excluding radiotherapic or surgical control
* Poor general condition
* Contraindication to general anesthesia
* Uncontrolled diabetes

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Debry, MD

Role: PRINCIPAL_INVESTIGATOR

Hopitaux Universitaires de Strasbourg

Locations

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Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre

Strasbourg, , France

Site Status

Countries

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France

References

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Schultz P, Vautier D, Atallah I, Gentine A, Debry C. [Reconstruction of the anterior mandibule using a porous titanium implant: a case report]. Rev Laryngol Otol Rhinol (Bord). 2008;129(3):201-5. French.

Reference Type RESULT

PMID: 19694164 (View on PubMed)

Other Identifiers

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3096

Identifier Type: -

Identifier Source: org_study_id